None listed
Conditions
Brief summary
This study will investigate the effectiveness of group-based Acceptance and Commitment Therapy (ACT) intervention in improving quality of life following treatment for early breast cancer. Who is it for? You may be eligible to join this study if you are a woman aged 18 years or above and have completed primary treatment for early breast cancer within the last two years. What does this study involve? In this study, all participants will receive the ACT intervention condition in random order. Participant will be randomly allocated to one of the following combination of study conditions: 1) Group A will first receive the ACT intervention program, then receive a breast cancer education (BCE) control program; 2) Group B will first receive the BCE control program, then cross-over to receive the ACT intervention program; or 3) Group W will first be on a 6-week wait-list during which participants receive neither programs, then they will receive the ACT intervention. As each study condition will be conducted weekly and will run for a 6-week period, with no allocated time interruption in between each condition, study duration is expected to be 12 weeks. In addition to attending group sessions, participation will also involve completing an ACT workbook. The workbook will guide participants through regular individual ACT practice outside group sessions. The ACT program will be delivered by an ACT-trained psychologist and will focus on providing participants with strategies based on the six core processes of ACT (Acceptance, Defusion, Self as Context, Values, Contact with the Present Moment, and Committed Action) aimed at enhancing participants' psychological flexibility and wellbeing. The BCE program will be facilitated by a trained breast care nurse and delivered by experts who will provide education relating to diet, physical activity, sexuality concerns, cancer biology, clinical physiology, relaxation techniques and sleep hygiene. At the beginning and end of each 6-week study condition period, questionnaires will be administered, blood and saliva samples will be collected, and blood pressure and resting heart rate will be measured. Participants will be followed-up at 6 and 12 months after the final session. Benefits of this study? Participating in this research has the potential to improve the quality of life of project participants and help them better manage anxieties related to fear of cancer recurrence. This study has been approved by the Human Research Ethics Committees of the Darling Downs Hospital and Health Services (DDHHS) and the University of Southern Queensland (USQ).
Interventions
Participants randomly assigned in the Acceptance and Commitment Therapy (ACT) intervention condition will receive a 6-week, 90 minute, weekly group-based face to face program delivered by two psychologists trained in ACT and using the same guidelines detailing the administration of ACT in individual interventions and adaptation of ACT for group interventions. For this study, both psychologists will use the same set of guidelines detailing adaption of ACT activities and schedule for a group-based
Participants randomly assigned in the Acceptance and Commitment Therapy (ACT) intervention condition will receive a 6-week, 90 minute, weekly group-based face to face program delivered by two psychologists trained in ACT and using the same guidelines detailing the administration of ACT in individual interventions and adaptation of ACT for group interventions. For this study, both psychologists will use the same set of guidelines detailing adaption of ACT activities and schedule for a group-based ACT intervention. The ACT intervention program focuses on providing participants with strategies based on the six core processes of ACT(Acceptance, Defusion, Self as Context, Values, Contact with the Present Moment, and Committed Action) aimed at enhancing their psychological flexibility and wellbeing through improving management of distress, mood and quality of life. Participation will also involve completing an ACT workbook and practicing ACT outside group sessions. Each participant will be provided with a printed ACT workbook. During each sessions they will be invited to complete relevant session items in their workbooks. At the end of each session, they will be encouraged to complete home-based activities and practice ACT individually before the next session. After 6 weeks in the ACT intervention program, participants will cross-over to a ‘usual care’ control program. Intervention adherence will be assessed, at the end of the study, by examining participant engagement with the ACT program as measured through auditing ACT workbooks and a thematic analysis of journal entries. The study will take place at St Andrew’s Hospital (Toowoomba, Queensland), where both intervention and control programs will be delivered in separate identical non-adjoining meeting rooms.
Sponsors
University of Southern Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Eligible study participants will include women aged 18 years or older who have completed primary treatment (surgery, neoadjuvant or adjuvant chemotherapy and radiation therapy) for early (stage 1 - 3) breast cancer in the previous two years.
Exclusion criteria
Participants will be excluded for any of the following reasons: (1) currently undergoing treatment with a psychiatrist or mental health therapist (however prior therapy does not disqualify from eligibility to participate in this research provided it occurred more than two years before the start of the study); (2) highly dependent on medical care; (3) having a history of or prior mood disorder diagnosed before cancer diagnosis; (4) psychiatric or neurological disorders; (5) unable to read or understand spoken English.
Outcome results
None listed